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A multicenter, randomized, controlled clinical trial (ARTEMIS) on the prognosis and safety of MR-guided Teneplase thrombolytic therapy in 4.5-24 hours of acute mild Disabling ischemic stroke.

A multicenter, randomized, controlled clinical trial (ARTEMIS) on the prognosis and safety of MR-guided Teneplase thrombolytic therapy in 4.5-24 hours of acute mild Disabling ischemic stroke.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083334
Enrollment
Unknown
Registered
2024-04-22
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic cerebrovascular disease

Interventions

Intravenous thrombolysis group:Intravenous injection of rhTNK-tPA, 0.25mg/kg
Non-intravenous thrombolytic group:Aspirin 100mg qd orally

Sponsors

Suzhou Science and Technology City Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: ? Age: 18-85 years old ? The normal time (LWT) is finally known 4.5-24 hours; ? NIHSS score 3-5 points; ? Disabling stroke; Including: 1) complete hemianopsia (NIHSS problem 3=2); 2) Severe aphasia (NIHSS problem 9=2); 3) blindness or loss of sensation (NIHSS problem 11=1); 4) The muscle strength score of any limb is more than 2 points (NIHSS problem 5 or 6=2); (5) Head MRI DWI/FLAIR imaging suggests mismatch areas (DWI sequence shows high signal, FLAIR sequence does not correspond to high signal). ? Subject or guardian sign informed consent;

Exclusion criteria

Exclusion criteria: ? History of major head trauma or stroke in the past 3 months; (2) Large cerebral infarction (infarct area > 1/3 middle cerebral artery blood supply area); ? Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extrinsic hematoma, etc.); ? In the past 1 week, the artery puncture in the part that is not easy to compress; (5) History of intracranial hemorrhage; ? Intracranial tumor, intracranial giant aneurysm; ? Intracranial or intraspinal surgery in the past 3 months; ? Major surgical operations in the past 2 weeks; ? Aortic arch dissection; ? Active visceral hemorrhage; Other planned surgical or interventional treatments; Being tested with an investigational drug or device; Women of childbearing age, pregnant women or breastfeeding women who refuse to take effective contraceptive measures despite negative pregnancy tests; 14 Participated in other clinical drug studies in the past 30 days.

Design outcomes

Primary

MeasureTime frame
Percentage of good 90-day outcomes;

Secondary

MeasureTime frame
90-day mRS 0-2 score ratio;The proportion of early neurological function improved by NHISS=2 points within 24 hours;Proportion of neurological deterioration within 72 hours (NIHSS score increase =4 points);EQ-5D score;

Countries

China

Contacts

Public ContactLij Jingwei

Suzhou Science and Technology City Hospital

ljw323@yeah.net+86 136 7515 8558

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026